Identity
- Trade Name
- ANTERION FDA UDI
- Generic Name
- Eye anterior segment analyser FDA UDI
- Model / Reference
- Software with HEYEX 2 V1.2.3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04059237000754 FDA UDI
- 510(k) Number
- K211817 FDA UDI
- FDA Product Code
- OBO FDA UDI
- GMDN Term
- Eye anterior segment analyser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Eye anterior segment analyser
Anterion by Heidelberg Engineering — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Eye anterior segment analyser.
- SPECULAR MICROSCOPE SP-1P — Topcon Corp. · Class II
- WaveLight — Alcon Laboratories, Inc. · Class III
- GALILEI — SIS AG, Surgical Instrument Systems · Class II
- ANTERION — Heidelberg Engineering · Class II
- ANTERION — Heidelberg Engineering · Class II
- ANTERION — Heidelberg Engineering · Class II
- TOMOCAP — Heidelberg Engineering · Class II
Cleared under the same submission
K211817 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Heidelberg Engineering
Sources (1)
- FDA UDI ec3cc072-ebbd-4e6f-86a6-c4a95d95662f 33 fields · synced May 30, 2026